MAUDE Adverse Event Report: MEDTRONIC MEXICO PACIFIC XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	PCU050300130
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The patient has a history of pad, hypertension, copd and coronary diagnostics.The physician used 2 pacific xtreme balloons to treat a cto in the superficial femoral artery as per ifu.It was reported both devices were prepped and loaded with no difficulty reported.The devices were passed through previously deployed stents with no resistance.During the first inflation both balloons ruptured while dilating a graft post laser atherectomy, a pin hole leak was noted at 6atms.Both devices were removed from the patient with no issues noted.Another device was used to treat and complete the procedure.No injury to the patient reported.
Additional Manufacturer Narrative
Evaluation summary: a visual and tactile inspections were performed.The purging phase was performed and no leak was detected.It was possible to insert, after flushing the guide wire lumen a 0,018¿¿ guide wire.The balloon was inflated till 10 bar, but neither leak nor pinholes were visible on the balloon and the pressure was maintained.No issues were found on the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PACIFIC XTREME
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22210 ; MX 22210
• MDR Report Key: 6713349
• Report Number: 9612164-2017-00895
• Device Sequence Number: 13713127
• Product Code: LIT
• UDI-Device Identifier: 08033477058504
• UDI-Public: 08033477058504
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K103464
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: PCU050300130
• Device Catalogue Number: PCU050300130
• Device Lot Number: 213172689
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Initial Date Received by Manufacturer: 06/15/2017
• Supplement Date Received by Manufacturer: 07/21/2017
• Initial Report FDA Received Date: 07/14/2017
• Supplement Report FDA Received Date: 08/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 86